Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The Associate Clinical Research Manager assists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Additionally, the Associate Clinical Research Manager acts as liaison between senior project team members and study subjects. The role involves actively participating and assisting with sponsor, investigator and research team communications.
What You'll Do:
• Actively participate with senior project team members to meet project needs, projections and deadlines.
• Oversee organization and accuracy of project documents.
• Work with management on understanding departmental needs and improving processes.
• Provide support for the study conduct, working directly with study monitor and study subjects.
• Oversee data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification.
Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills, Abilities:
• Basic knowledge of Phase I processes and clinical study operations
• Fundamental knowledge of FDA regulations and ICH GCP guidelines
• Basic computer skills with working knowledge of Microsoft Office applications
• Time management and multi-tasking skills
• Written and verbal communication skills
• Ability to prioritize workload and adapt to changing study needs
• Ability to act as a liaison between external and internal groups.
Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.
